Comparison of Epidural Labor Pain Relief Techniques on Maternal and Fetal Outcomes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-26

Study Completion Date

2016-01-27

Brief Summary

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The primary objective of this study is to compare the onset and duration of the initial dose of medications given through three different epidural (conventional epidural, combined spinal epidural and dural puncture epidural) techniques for labor pain relief.

The secondary objective of this study is to compare the fetal effects of these three epidural labor analgesia techniques.

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Detailed Description

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Conditions

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Laboring Women Requesting Neuraxial Labor Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial with computer generated (Microsoft Excel 2015) assignment placed in sealed envelopes.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Anesthesiologist performing technique and bedside nurse instructed not to reveal randomization arm to the patient or study co-investigator who was waiting outside the room, and notified only after completion of the neuraxial placement protocol.

Study Groups

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Epidural Technique

Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 15 mL load over 5 min

Group Type ACTIVE_COMPARATOR

Epidural Technique versus Dural Puncture Epidural Technique versus Combined Spinal Epidural Technique

Intervention Type PROCEDURE

Three different techniques, using the same medications (bupivacaine and fentanyl)

Combined Spinal Epidural Technique

Bupivacaine 2.5 mg with Fentanyl 25 mcg

Group Type ACTIVE_COMPARATOR

Epidural Technique versus Dural Puncture Epidural Technique versus Combined Spinal Epidural Technique

Intervention Type PROCEDURE

Three different techniques, using the same medications (bupivacaine and fentanyl)

Dural Puncture Epidural Technique

Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 15 mL load over 5 min

Group Type ACTIVE_COMPARATOR

Epidural Technique versus Dural Puncture Epidural Technique versus Combined Spinal Epidural Technique

Intervention Type PROCEDURE

Three different techniques, using the same medications (bupivacaine and fentanyl)

Interventions

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Epidural Technique versus Dural Puncture Epidural Technique versus Combined Spinal Epidural Technique

Three different techniques, using the same medications (bupivacaine and fentanyl)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 1\. Nulliparous (first baby) parturient 2. Singleton, vertex gestation at term (37-42 weeks) 3. Less than 5 cm dilation 4. Desires an epidural technique for labor analgesia

Exclusion Criteria

\- 1. Current or historical evidence of clinically significant disease or condition, including diseases of pregnancy (i.e preeclampsia, gestational diabetes) 2. Any contraindication to the administration of an epidural technique 3. History of hypersensitivity or idiosyncratic reaction to local anesthetic or opioid medications 4. Current or historical evidence of a disease which may result in the risk of a cesarean delivery.

5\. Evidence of anticipated fetal anomalies

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No